In April 2019, the Food and Drug Administration issued two Warning Letters to medical device manufacturers, reminding industry that the agency will take enforcement action against unlawful promotion when it sees fit. One Warning Letter addressed promotional claims and misleading statements provided in marketing materials, including promotion of an unapproved device. The other Warning Letter related to modifications to an in-vitro diagnostic (IVD) assay that resulted in adulteration and misbranding of the product.

For a number of reasons, FDA has historically issued few Warning Letters related to medical device products in the area of promotion and marketing. In addition to its relative rarity, FDA’s April action is also notable because it demonstrates that the agency will take enforcement action, despite highly-publicized court challenges that have called into question the agency’s authority.

FDA issued a Warning Letter to a medical device company that manufactures a facial implant device due to a number of deficiencies found during a 2018 inspection. Based on the inspection, FDA found that the company’s marketing materials for the device, including instructional videos and training materials, promoted the product for purposes other than its 510(k)-cleared intended use.

The Warning Letter cited a number of examples of company materials that unlawfully marketed the product for a major change or modification in intended use, including:

a 3-minute instructional video covering the materials and procedures for use in lip augmentation with images that showed, and narrative that described, the implant of the device in the upper and lower lips of live patients; and

a 12-item checklist documenting the training provided to medical directors and surgeons on the use of the product, including a process for implantation of the device in the lips (i.e., “roll the lip up such that the wet dry border faces up toward the ceiling during dissection to help surgeon not veer from the wet dry border”).

FDA noted that the promoted use was a major change or modification that did not fall within the device’s current 510(k) clearance due to the heightened risks to the patient with augmentation of the lips, which may cause migration or protrusion of the implant.

The agency concluded that the firm failed to have an approved premarket approval application (PMA).

The Warning Letter also included a summary of certain misleading statements included in the firm’s marketing materials, including:

the firm’s website included references that implied FDA approval of the device. For example, the website included a statement that the device is “a patented, FDA approved device designed for tissue augmentation of the face and has undergone extensive clinical testing to ensure its safety and efficacy.” FDA noted that the device was not approved, but was a 510(k)-cleared device; and

the Events page on the firm’s website stated, “say hello and learn more about our flagship products – [lip implant device name and facial implant name],” but the lip implant device was not cleared or approved by FDA.

In the other April Warning Letter, FDA noted a number of deficiencies related to a 2018 inspection.

The company manufactured and distributed Class I and II in-vitro diagnostic reagents, including a chemistry analyzer and associated rotor panels/assays. FDA found that a particular assay had been modified and was adulterated and misbranded (because it lacked a new PMA and 510(k).

AGG Observations

CDRH does not often issue Warning Letters regarding medical device advertising and promotion, and certainly FDA’s Center for Drug Evaluation and Research (CDER) issues more enforcement letters to pharmaceutical companies. However, medical device manufacturers should be aware of FDA’s regulation in this space, and FDA will take enforcement action when it deems appropriate.

FDA closely monitors modifications of all device products, including IVDs. Therefore, before any modification is made, it is important for a company to review FDA regulations, consult available guidance and, if appropriate, consult with counsel or regulatory consultants regarding when and whether a new submission is required.

Once a modification is made, it is important to update related policies and procedures (e.g., quality-related procedures), because they must be accurate and consistent with the current product specifications.

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